| Class 2 Device Recall Power Knee | |
Date Initiated by Firm | August 29, 2022 |
Date Posted | September 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1821-2022 |
Recall Event ID |
90775 |
Product Classification |
Assembly, knee/shank/ankle/foot, external - Product Code ISW
|
Product | OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA01001L
OSSUR Power Knee REF PKA01001T |
Code Information |
Model Number / UDI-DI Code
PKA10001 / 05690967648381
Serial Numbers:
HF511081;
HF511095;
HF511100;
HF511102;
HF511116;
HF511133;
HF511323;
PKA10003 / 05690967648749
Serial Numbers:
HF511029
HF511036
HF511042
HF511050
HF511060
HF511061
HF511065
HF511070
HF511071
HF511072
HF511075
HF511077
HF511082
HF511084
HF511096
HF511098
HF511099
HF511101
HF511104
HF511105
HF511108
HF511110
HF511115
HF511119
HF511121
HF511122
HF511123
HF511124
HF511126
HF511127
HF511128
HF511130
HF511131
HF511132
HF511136
HF511137
HF511138
HF511142
HF511144
HF511146
HF511148
HF511149
HF511151
HF511155
HF511159
HF511162
HF511163
HF511164
HF511165
HF511168
HF511169
HF511170
HF511171
HF511173
HF511176
HF511178
HF511179
HF511181
HF511182
HF511183
HF511185
HF511187
HF511188
HF511191
HF511192
HF511193
HF511194
HF511195
HF511198
HF511199
HF511200
HF511201
HF511204
HF511206
HF511207
HF511208
HF511212
HF511213
HF511216
HF511217
HF511218
HF511219
HF511221
HF511222
HF511223
HF511224
HF511225
HF511227
HF511228
HF511229
HF511230
HF511231
HF511234
HF511235
HF511236
HF511244
HF511245
HF511246
HF511247
HF511248
HF511250
HF511251
HF511253
HF511254
HF511255
HF511256
HF511257
HF511259
HF511260
HF511261
HF511262
HF511263
HF511264
HF511265
HF511267
HF511268
HF511269
HF511270
HF511274
HF511276
HF511277
HF511278
HF511279
HF511280
HF511281
HF511282
HF511283
HF511285
HF511286
HF511287
HF511293
HF511294
HF511295
HF511296
HF511298
HF511299
HF511300
HF511301
HF511302
HF511303
HF511306
HF511307
HF511308
HF511309
HF511311
HF511313
HF511314
HF511315
HF511318
HF511320
HF511321
HF511322
HF511325
HF511326
HF511327
HF511328
HF511338
HF511339
HF511340
HF511341
HF511342
HF511344
HF511345
HF511347
HF511348
HF511349
HF511350
HF511351
HF511352
HF511355
HF511356
HF511358
HF511360
HF511361
HF511362
HF511366
HF511367
HF511368
HF511369
HF511370
HF511372
HF511373
HF511376
Note - These Models below are Loaner devices and are under Firm's control
PKA01001L / 05690967642822
Serial Numbers:
HF511037
HF511091
HF511324
HF511143
HF511363
HF511375
HF511377
HF511378
HF511184
HF511203
HF511237
HF511252
HF511273
HF511275
HF511304
HF511330
HF511374
HF511047
HF511094
PKA01001T / 05690967642839
Serial Numbers:
HF511177
HF511059
HF511038
HF511054
HF511058
HF511046
HF511064
HF511080
HF511073
HF511076
HF511079
HF511028
HF511249
HF511240
HF511241
HF511196
HF511051
HF511135
|
Recalling Firm/ Manufacturer |
Ossur Americas 27051 Towne Centre Dr Foothill Ranch CA 92610-2804
|
For Additional Information Contact | Chris Lohrman 949-382-3715 Ext. 102 |
Manufacturer Reason for Recall | Battery may dislodge from the Power Knee |
FDA Determined Cause 2 | Device Design |
Action | On 08/29/2022, The firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that reports have been received of units where the battery dislodged from the Power Knee units, causing loss of power to the device. This may cause an increase risk for stumbles or falls, potentially leading to an injury.
Customer are being instructed to implement a correction to retrofit a security tab to their units. The retrofit kit will be provided with clear instructions for attaching the security tab to the device. In addition, customer are asked to:
1. Pass this notice to those who need to be aware within their organization or to any organization where Power Knee devices have been transferred.
2. Reconcile Ossur s records with their own to ensure all devices are accounted.
3. Once all users have been identified and the retrofit kits have been received, customers will need to schedule each individual to come into their clinic to complete the retrofit process.
4. Sign the acknowledgment form confirming receipt of this notice and that the retrofit process has been completed for all affected devices.
Ossur is here to support customers through the process. Contact customer service for further information and assistance. Tel: 1-800-233-6263. |
Quantity in Commerce | 190 devices |
Distribution | U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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