The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1098-2023·Announced 2023-02-15

Zimmer Identity Shoulder Resection Planer Units Recalled for Malfunction

Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer due to defects discovered during training testing. Some units are unusable, potentially affecting surgical performance in shoulder procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (surgical instrument that may malfunction) where no injuries have been reported yet. The defect was discovered during testing before clinical use, but a non-functioning surgical planer could directly impact surgical outcomes if not detected during use.

Plain-English summary

Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer (models 35mm, 40mm, 45mm, 50mm, and 55mm) distributed nationwide in Arkansas, California, Illinois, Michigan, New Jersey, New York, Oklahoma, Pennsylvania, Texas, and Washington. The recall was initiated after two planer units were found to be unusable during sawbones shoulder training.

The defects affect multiple item numbers and lot codes: SBHA4035 (lots ZB7298335, ZB7234012, ZB3987432), SBHA4040 (lot ZB7234013), SBHA4045 (lot ZB7234014), SBHA4050 (lots ZB7234015, ZB3987435, ZB3986427), and SBHA4055 (lots ZB7252285, ZB3986428, ZB3987436). The defective units may not perform as intended during shoulder surgical procedures.

Healthcare facilities and surgeons who have received affected units should identify any devices matching the recalled lot numbers and contact Zimmer, Inc. for instructions on replacement or product return. Do not use any units from the recalled lots.

The recalled product

Product
Identity Shoulder System Resection Planer 35mm Resection Planer
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical / Orthopedic
Hazard
Affected units
84

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Item Number: 1) SBHA4035
  • Lots: ZB7298335 (UDI: (01)00889024628052(11)220725(10)ZB7298335)
  • ZB7234012 (UDI: (01)00889024628052(11)220512(10)ZB7234012)
  • ZB3987432 (UDI: (01)00889024628052(11)220308(10)ZB3987432) 2) SBHA4040
  • Lot ZB7234013 (UDI: (01)00889024628069(11)220512(10)ZB7234013) 3) SBHA4045
  • Lot ZB7234014 (UDI: (01)00889024628076(11)220525(10)ZB7234014) 4) SBHA4050
  • Lots: ZB7234015 (UDI: (01)00889024628083(11)220624(10)ZB7234015)
  • ZB3987435 (UDI: (01)00889024628083(11)220312(10)ZB3987435)
  • ZB3986427 (UDI: (01)00889024628083(11)220307(10)ZB3986427) 5) SBHA4055
  • Lots: ZB7252285 (UDI: (01)00889024628090(11)220704(10)ZB7252285)
  • ZB3986428 (UDI: (01)00889024628090(11)220307(10)ZB3986428)
  • and ZB3987436 (UDI: (01)00889024628090(11)220612(10)ZB3987436).

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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